Below is URGENT notification for your immediate action.
Please confirm if you have shipped any of the affected units to customers and therefore need to take immediate action on this recall.
We need to receive all your response by 3 pm Singapore time today (28 Aug).
Bard Peripheral Vascular (BPV) became aware of several complaints reporting that an end of the DuaLok Breast Lesion Localization Wire was protruding through the device packaging. When this occurs the sterility of the product could be compromised and/or individuals could puncture themselves or obtain a small laceration while handling the package. The resulting investigation (SPA-14-06-02 rev1) identified that the packaging was inadequate to prevent the product. As a result on 8/25/14 the Corporate PAT approved a voluntary recall of 207 lots of DuaLok Breast Lesion Localization Wires. Attached are the signed recall notice, approved SPA, and FAQ’s. Today (8/27/14) BPV sent out recall notices to the affected US customers and sales representatives.